Transforming biopharmato accelerate the development and commercialization of innovative therapies for patients worldwide

Advisory Services

Strategic problem-solving and evidence generationIndustry-leading perspectives

Our team of seasoned management consultants draw upon their extensive advisory services experience and focus on accelerating superior outcomes guided by connected insights, strategic thinking and actionable solutions.

Domain expertise with scale and reachGlobal footprint and scale

Quintiles Advisory Services brings deep expertise across multiple domains and harnesses the power of hybrid teams including our 1,100 medical doctors and more than 1,050 PhDs across our global organization, with over 30 years of clinical research and commercial experience and ability to serve approximately 100 countries to help bring actionable insights and solutions.

Rich data integrationInnovative technology

Through the strength of our extensive data and analytical engines, we provide evidence to support asset development, guide the creation of effective implementation plans, and deliver high quality, integrated global solutions.

Strategy to operationsAdvise to operate

We offer strategic advice which can lead to fulfilling operational partnerships with Quintiles, from outsourcing of clinical development and mature products to joint operations of functions throughout the value chain.

What makes us differentQuintiles Advisory Services is built on focus, knowledge and an understanding of healthcare.

Who we are

Quintiles Advisory Services, the consulting arm of Quintiles, is a different kind of healthcare advisory group – built on a blend of deep industry and therapeutic expertise, strategic problem-solving skills and rich data assets.

We bring a broad understanding of end-to-end drug development and healthcare delivery to help firms develop the strategies and capabilities needed to develop and launch products with the greatest potential for commercial success and patient outcomes, based on the right evidence needed to demonstrate value.

We operate on the principle that the best evidence is based on connected, broad insight which results in actionable solutions, faster implementation and ultimately superior outcomes/value.

Quintiles Advisory Services core solutionsOur ability to leverage the broader operational capabilities across the global Quintiles organization, allows us to also bring perspectives and solutions developed through real-world experience across the value chain.

Market Intelligence & Market Planning

Use advanced primary research methodologies and decision modeling to generate unique market insights and build plans for clinical and commercial development throughout the product life cycle.

Technical & Commercial Due Diligence Help biopharma clients decide whether to

develop or acquire assets tailored to the portfolio, therapeutic area/disease or asset level using real-world data and technical probability analysis.

Integrated Asset Development Planning

Deliver key asset planning components required for successful asset development and commercialization including the target product profile, clinical development plan, market access plan, launch plan and commercialization.

Clinical Development TransformationLeverage novel approaches for clinical

trial design and execution that improve the probability of commercial success and maximize return on investment for products in development.

Regulatory & Safety OptimizationHelp companies assess and optimize

the value, approach and key activities required to manage their regulatory, safety and benefit risk management (BRM) capabilities, including virtualization.

Enterprise Quality Management & Compliance

Support clients in all aspects of proactive and reactive global quality and regulatory compliance, including developing regulatory strategies, conducting compliance audits & gap analyses, vendor audits and preparing responses to FDA 483 citations and warning letters.

Value & Outcomes StrategyHelp biopharma companies design,

develop and execute evidence plans that clearly articulate and support the value story for a product or device with rigorous, compelling data targeted to key healthcare system stakeholders, including health economics and outcomes research, patient-centered endpoints, market access and policy analysis.

Innovative Launch StrategyProvide asset and market-tailored

launch strategy and support which take into account local market variability, evidence expectations, higher standards for market access, new channels and stakeholders.

Mature Product ManagementHelp pharmaceutical companies

consider alternatives for creating value from their mature products, including sales and marketing promotion and divestment. Quintiles also offers outsourcing capabilities to develop and implement programs aimed at capturing incremental value.

End-to-end PartnershipsDesign and execute custom strategic

partnership models for biopharma companies, including providing bench strength or outsourcing capabilities across the product life cycle, from strategy and early phase to post-authorization and commercial.

Other focus areas

• Biosimilars

• Personalized Medicine and Diagnostics

• Orphan Drugs

• Predictive Analytics

Our peopleElgar Peerschke President, Advisory Services

Elgar brings more than 25 years of experience in providing advisory solutions to life sciences clients

across the global healthcare industry.

Prior to joining Quintiles, Elgar served as a senior executive in its Global Healthcare Practice Group at Bain & Company and spent more than a decade at McKinsey and Company in various leadership roles.

John Doyle, DrPH, MPH Senior Vice President, Advisory Services

John leads the Value & Outcomes efforts at Quintiles and maintains an

adjunct faculty position at the Mailman School of Public Health at Columbia University.

Prior to joining Quintiles, John served as the President and Chief Operating Officer of Analytica International, Inc., and led a health economics research group at Bristol-Myers Squibb Company.

Avi Kulkarni, PhD Senior Vice President, Advisory Services

Avi brings more than 25 years of life science experience, and a proven

track record of thought leadership in optimizing the research development process to improve the delivery of tailored therapeutics.

Prior to joining Quintiles, Avi was a partner at Strategy& (formerly Booz & Company and Booz Allen & Hamilton) and led the R&D and Medical Transformation business.

Adrian McKemey, PhD Senior Vice President, Advisory Services

Adrian focuses on business transformation, portfolio management,

risk partnering, scenario planning and outsourcing strategies.

Prior to joining Quintiles, Adrian worked in the Health Care practice at BCG and was a particle physicist and a tenured faculty member at Brunel University in London.

Mark Mozeson Senior Vice President, Advisory Services

With nearly 30 years of life science experience, Mark ensures the most

senior-level oversight and management for strategic accounts and customer relationships for Quintiles Advisory Services.

Prior to joining Quintiles, Mark was a partner at Oliver Wyman and led the Health & Life Science practice.

Frederic “Rick” Sax, MD Senior Vice President, Advisory Services

Rick’s career spans nearly 20 years in the biopharmaceutical industry,

leveraging drug development design expertise to help partners make knowledge-based decisions

Prior to joining Quintiles, Rick served as the Vice President, Clinical Design Strategies of AstraZeneca’s clinical development leadership team

Dean Summerfield, DPhil Senior Vice President, Advisory Services

Dean has nearly 20 years of experience in providing advisory

solutions to life sciences clients.

He leads advisory services for Integrated Healthcare Services (IHS) at Quintiles and is Managing Director for the European Advisory Services group.

Marc Hennebert Senior Vice President, Advisory Services

Marc has nearly 30 years of experience with emphasis on

building and leading teams for complex consulting engagements.

Prior to joining Quintiles, Marc set-up new practices for IMS Health, served as managing partner of the Life Science & Chemicals practice for Strategic Decision Group and as a partner at Arthur D. Little.

Case study

Client situation: A leading biopharmaceutical company wanted to evolve their clinical research and operations to increase speed and agility of development and improve the probability of success for their pipeline while effectively managing R&D spend.

Results: The company transformed its R&D into a lean virtual operation, enhancing its strategic capabilities while leveraging external excellence in clinical operations. The partnership model enabled the company to increase study volume by 50%, achieve a 40% internal reduction in clinical development FTEs per study and also avoid costly investments in redundant capabilities and IT systems. In addition, Quintiles’ scientific expertise in new therapeutic areas, market access knowledge and proficiency was important in helping the client expand their portfolio and optimize clinical development.

Our actions: Quintiles responded by bringing our subject matter expertise in clinical development, process excellence and change management to partner with the client. Together we created and fully implemented a flexible end-to-end operating model, encompassing strategy and operations from early clinical phase to launch and life cycle management.

• Approximately 200 process maps jointly developed

• Detailed RACI created to streamline distribution of work

• Organizational design and modeling for client

• Partnership manual linked with training

• Aligned metrics at study, program and executive levels

• Technology mapping and strategy

• 100+ people from both organizations contributed as team members and became change champions

Partnership Governance Structure

Partnership Executive Committee

Executive Co-chairs

Partnership Directors Finance Clinical

Science LeadStrategic Drug Dev.

Partnership Operating Committee Quality Council

Partnership Mgmt.

DeliveryLeads Finance Information

TechnologyProcessLeads

Clinical Quality Leads

Partnership Management Office Innovation and Technology Committee Resourcing Committee

ProcessLeads Metrics Leads Innovation

LeadsTechnology

Leads HR Leads

Joint Team

Partner

Sponsor

Program 1 Program 2 Program 3

Program Directors Program Directors Program Directors

Study 1 Study 2

PMs PMs

Study 1 Study 2

PMs PMs

Study 1 Study 2 Study 3

PMs PMs PMs

Work Plan for Initial Project Phase

Week 1-6 Week 7-13 Week 14-16

Operating Model Detailed Design Roadmap Implementation

Operating Model Design End-to End Process Design

Organizational Plan

Governance Design

Productivity Assessment Performance/Contracting Design

Technology Assessment Technology Plan

Transition Risk Assessment Transition Design

Resource Management/Talent Retention

Communications

Project and Change Management

Operating Model Workshop

Interim Readout(top line estimates)

Interim Readout(detailed design)

Final Readout

Implementation Roadmap and Plan

High-Level Operating Model Transformation

FunctionCurrent State

Future StateTA #1 TA #2 TA #3

Clinical Research Sponsor Sponsor Mixed Mixed

Medical Writing Sponsor Sponsor Mixed Mixed

Project Mgmt Mixed Mixed Partner Partner

Data Mgmt Mixed Sponsor Sponsor Partner

Biostatistics Sponsor Sponsor Partner Partner

Vendor Mgmt Sponsor Mixed Mixed Partner

Site Monitoring Partner Partner Partner Partner

Clinical Supplies Sponsor Mixed Mixed Mixed

Quality Assurance Sponsor Sponsor Sponsor Mixed

Contact usToll free: 1 866 267 4479 Direct: +1 973 850 7571Website: www.quintiles.com/advisoryservices Email: advisoryservices@quintiles.com C

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